Recall Z-1483-2021 ยท DPS Electrocardiograph
Welch Allyn Inc Mortara
ELI 380 Electrocardiograph, with AM12M Acquisition Module accessory. Impacted software version of the AM12M is version 1.5.1 - Product Usage: indicated for use on adult and pediatric populations.
| Date | Mar 31, 2021 |
| Status | Terminated |
| Reason | Devices do not meet IEC 60601-2-27 requirements as labeled. |
| Root cause | Process control |
| Action | Recall notification letters were mailed to customers notifying them of the potential issue with recommended actions beginning April 7, 2021. The notification letter includes an acknowledgement form that must be returned to the recalling firm. Once the customer confirms the impacted units are in possession, the recalling firm will arrange for an exchange AM12M to be provided. The recalled unit will be returned to the recalling firm's service center for processing. |
| Quantity | 27 units |
| Distribution | US Nationwide distribution in the states of CA, CO, FL, GA, IN, LA, NC, NJ, NV, NY, OH, OK, TX, UT, and VA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K142105 | ELI 380 ELECTROCARDIOGRAPH Mortara Instrument, Inc., Sep 5, 2014 |